Proven process for micro medical device development

1. Keywords: micro medical device, medical device development, micro medical device design Word Count: 400 Proven process for micro medical device development Cutting edge micro medical devices and drug delivery systems have been used for decades and now used in a multiple medical and drug delivery device market segments. There are numerous micro medical devices available in the market and newer technologies are being developed for the purposes of non-invasive surgery, pain management, and patient and physician compliance. Micro Engineering Solutions is engaged in the design and development of every many types of micro medical device and drug delivery systems and partners with original equipment manufacturers (OEMs). Methods of drug delivery include transdermal, intraocular, sub-cutaneous, inhalation, swallowable, and injectable. The various stages of the micro medical device development process as adopted by the company have been described here. Designing The product designers of Micro Engineering Solutions design the micro medical devices in collaboration with OEM clients. The micro medical device design is thoroughly analyzed for its pros and cons and several designs are considered in the initial stage of development. The scalability of the design and the time required to manufacture the devices according to the design are also assessed by the design, material, and micro manufacturing engineering experts. The design engineers of the company possess the knowledge about the functioning of various materials and mechanical systems at the micron level. With decades of experience, manufacturing issues are reviewed using proven risk mitigation strategies for micron tolerance devices. Material specialists select suitable materials for clinical, implantable, and Class III, II, and I micro devices, down- selecting the materials befitting of device function as well as highly micro fabrication technology. Design analysis is completed using computational analysis such as finite element analysis, fluid dynamics, mold flow analysis, and capillary and surface finish analysis. This theoretical methods ensure that any concern regarding the design is detected early

2. on in the manufacturing process. Design analysis ensures that only the best quality designs are implemented. Design brainstorming for alternate designs are included and reported for design history and intellectual property enhancement and claims. Empirical data to support these claims are tested and confirmed as support to all design claims. Pilot production The manufacturing process and assembly strategy to be used for the development of the micro medical devices are tested. The pilot production stage implements the chosen design or parallel designs into manufacturing stage according to the given specifications. The product obtained in this stage is mechanically tested in a physical lab and wet lab to test design intent in all tested designs are suitable for further clinical trials and scalability. The device produced in the pilot production stage is also tested for safety and effectiveness. Pilot production ensures that the design is appropriate for the purpose, the production units are working well and the manufacturing process is ready to begin mass production. Clinical trials The micro medical device is subjected to clinical trials to ensure that it is safe to use and performs as per its design. The tests also ensure that the device adheres to the regulatory requirements. Mass production is initiated after validation and/or pre- clinical, and clinical trials are successfully completed.